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EU Court Ruling Throws Confusion On Need For Notified Body Unannounced Inspections

The European Court of Justice judgment on the TÜV Rheinland notified-body liability case raises more questions than answers. In particular, there is uncertainty over its impact on the need for notified bodies to perform unannounced audits.

Legal Issues Regulation Europe

Unlocking Legalities: Gorsuch’s Impact May Be Felt On Free Speech, Preemption

Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.

Unlocking Legalities Legal Issues Policy

'Selective' JDRF Backs Israeli Injectable Blood Glucose Monitor

An Israeli start-up developing an injectable, miniature continuous blood glucose monitoring implant has secured funding from the Juvenile Diabetes Research Foundation (JDRF) to speed up product development. The investment will be used to bring GluSense closer to its first in-human clinical trial.

Diabetic Care Innovation Deals

Device Week – Feb. 17, 2017

On this week's Medtech Insight podcast: US House Ways and Means Committee sets out plans for the next two years, including a review of all taxes and fees connected to the Affordable Care Act; Allergan and Hologic enter into separate big-money acquisitions in the aesthetics devices arena; a deep-dive look at the osteoporosis diagnostics market.

Regulation Policy Deals

Recent Tweets from Medtech Insight

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Regulation Policy Quality Control

More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

Quality Control Compliance Regulation

CMS Nominee Seema Verma Urges Caution On Competitive Bidding Program

Seema Verma, President Trump’s pick to run the US Medicare agency, told the Senate Finance Committee that rural areas should not have to comply with CMS’ medical supplies competitive-bidding program if it is not a good fit. Verma was also questioned on changes she might make to the Affordable Care Act and the Medicare program, but did not offer many specifics.

Policy Reimbursement

China To Get Tougher On Recalls Beginning In May

More stringent recall rules in China will see the maximum penalty for failure to carry out a mandatory recall rise from three times the value of a medical device, to up to ten times its value.

Recalls China

European Court Weighs In On TÜV Rheinland PIP Case; Will It Vindicate The Notified Body?

TÜV Rheinland has had a nightmare time in national courts on liability questions relating to its involvement with the notorious PIP breast implants. Will new European Court of Justice legal findings vindicate it sufficiently to persuade national courts? And what will this mean for notified bodies more generally?

Legal Issues Europe

Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues

House Ways And Means Committee Membership, 115th Congress

The chart below displays the updated membership of the committee, which has important oversight on health and tax policy matters. It specifies which members sit on the Health Subcommittee.

Legislation Policy

House Panel Plans Oversight On Device Tax, MACRA, Trade Negotiations

The US House Ways and Means Committee will focus oversight actions this Congress on Affordable Care Act issues including device tax repeal, Health and Human Services priorities – including implementation of provider payment reforms – and overseas trade negotiations, the panel agreed Feb. 14.

Legislation Policy

Quality Control Explore this Topic

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Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues

Q4 Recalls Snapshot: Numbers Dip Slightly But Remain High; Sterility Troubles Bubble To Surface

The number of device recalls fell slightly in the final quarter of 2016. While troubles with software and mislabeling continue to be a thorn in industry's side, problems with sterility popped up as the third most common reason for a product recall.

Recalls Quality Control

An Auditor's Take: Unrealistic EU Demands Are Causing Notified Body Exodus, Potential Company Collapses

Demands related to auditor education, experience and affiliation are making it difficult for notified bodies to retain and hire staff. This comes on top of much tougher regulatory requirements. One notified body auditor explains why the situation might be killing notified bodies when they are needed most.

Regulation Europe

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Allergan Pays $2bn-Plus For Zeltiq, Expanding Aesthetics Business

Zeltiq's CoolSculpting body-contouring system will be the third "pillar" in Allergan's aesthetics business, along with its existing facial aesthetics and plastic and regenerative surgery lines, the company says.

Aesthetics Deals Companies

Latest From Commercial

Integra Aims To Bolster Neurology Portfolio With J&J Codman Buy

Only a month after buying the tissue regeneration company Derma Sciences, Integra has announced a much larger acquisition for Codman Neurosurgery. The company says the buy would complement its current neurosurgery portfolio and boost its global reach.

Neurology Deals

£9m NHS Savings With HeartFlow 'Virtual FFR' Gets NICE Nod

UK's National Institute for Health and Care Excellence has recommended the HeartFlow FFRct Analysis for stable patients with a suspected myocardial infarction. NICE was won over by the potential £9m savings that the technology can bring to the National Health Services in the next five years.

Cardiology Diagnostic Imaging

Hologic Stitches Medical Aesthetics Into Women's Health

Hologic is acquiring Cynosure for $1.65bn, saying medical aesthetics will complement its existing OB/GYN and women’s health businesses. It is the latest in a series of recent moves intended to accelerate Hologic’s growth.

M & A Deals

Europe's TAVR No. 4 Buys Into Mitral Valve Space

Transcatheter aortic valve replacement specialist Symetis has made its maiden acquisition, buying preclinical-stage mitral valve repair firm Middle Peak Medical.

Cardiology M & A

Expanding Elderly Population Gives Leg Up To Osteoporosis Dx Growth

The global market for osteoporosis diagnostic products is expected to expand from $253m in 2015 to $304m by 2020, fueled by a rising aging population and the need to test for osteoporosis and associated fracture risk. This article offers an in-depth look at the growth markets for both bone densitometer testing and biochemical marker tests, as well as the evolving competitive landscape, and the drivers and barriers to market entry.

Orthopedics Market Intelligence

Anatomy Of A Medtech Carve-Out

Divesting an underperforming and/or non-core asset could help reinvigorate a medtech business. But what are the issues that arise for the sellers of those assets, as well as the buyers, during the carve-out process? Jane Hobson and Phelim O'Doherty of Baker McKenzie discuss what the common issues are and how to address them in this guest column.

Business Strategies Legal Issues

Clinical R&D Explore this Topic

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OUS Approvals Analysis: Medtronic, Abbott, Abionic Lead 2017 Upswing

The 20 non-US medical device approvals in January, including eight in in vitro diagnostics, four in orthopedics, and three in cardiovascular devices. Big medtech players Medtronic and Abbott, accompanied by much smaller Swiss IVD firm Abionic, led the charge and bagged more OUS approvals than most.

Approvals Research & Development Medical Device

Latest From Research & Development

Starts & Stops: Abbott's Inherited Products Add To Spike In Suspensions

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. This edition highlights an apparent trial-suspension spike in the past month, including three studies that were stopped by Abbott evaluating products it inherited from its acquisition of St Jude Medical.

Clinical Trials Research & Development

US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance

The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.

Approvals Innovation

Abbott Finally Joins MRI-Compatibility Club In US CRM Market

The firm’s Assurity MRI pacemaker and Tendril MRI pacing lead, acquired in its recent St. Jude Medical deal, gained US FDA approval after some delay. Lack of this designation has been a competitive challenge for the business in the past year.

Cardiology Approvals

Start-Up Spotlight: Bio2 Technologies Inc., Space-Tech Biomaterial For Extremities Surgery

Originating from aerospace technology, Bio2 Technologies’ Vitrium biomaterial platform is designed for multiple applications across musculoskeletal surgery. The firm has already begun commercialization in the US and expects to get a CE mark later this year.

Orthopedics StartUps and SMEs

VolitionRx Gets Green Light For Nucleosome-Based Colorectal Cancer Test

Blood-based cancer diagnostics firm VolitionRx CE-marked a new colorectal cancer-screening test that has shown the potential to reduce unnecessary colonoscopies by up to 25% when combined with the fecal immunochemical test (FIT) score.

Cancer In Vitro Diagnostics

Abionic's New POC Sepsis Test On Rapid Move To Market

Swiss start-up Abionic has CE marked rapid tests for sepsis and iron deficiency, designed to run on its diagnostics platform abioSCOPE. The new sepsis test is based on a new biomarker PSP which has shown to be superior to current tests in detecting this life threatening condition early.

In Vitro Diagnostics Approvals